Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Pfizer Healthcare India Private Limited | Anakapalli, India | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyOct 18, 2022 · 7 inspections, 1 with FDA action |
Recalls
- Aug 22, 2022 · Class I · Pfizer Inc.
Presence of particulate matter
Lots: Lot#: EA7470, Exp 6/1/2023 - Jul 13, 2022 · Class I · Pfizer Inc.
Presence of particulate matter: particulate identified as a beetle.
Lots: Lot #: DX9067, Exp 5/1/2023 - Dec 23, 2014 · Class II · Hospira Inc.
Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.
Lots: Lot 35-844-DJ, Exp 11/01/2015 - Oct 6, 2014 · Class I · Hospira Inc.
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Lots: One shipment of Lot #: 33-750-DJ; Exp 1SEP2015 to The Harvard Drug Group, Livonia, MI - Apr 2, 2014 · Class I · Hospira Inc.
Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during a retain sample inspection where the glass vial contained visible embedded metallic particulate and free floating metallic particulates were also found in solution.
Lots: Lot #s: 29-614-DJ, 29-615-DJ, 29-616-DJ, 29-617-DJ, 29-628-DJ, 29-629-DJ, 29-630-DJ, Exp 05/01/2015 - Dec 12, 2013 · Class II · Hospira Inc.
Presence of Particulate Matter: Glass defect located on the interior neck of the vial identified glass surface abrasions and visible embedded particulate matter which could result in the potential for small glass flakes or embedded metal particulate to become dislodged into the solution.
Lots: Lot #: 27-568-DJ*, Exp 03/15, Note * may be followed by 01 - Oct 11, 2013 · Class II · Hospira Inc.
Presence of Particulate Matter: Visible particles embedded in the glass identified during a retain sample inspection.
Lots: Lot #: 27-570-DJ, Exp 03/01/15 - Aug 14, 2013 · Class II · Hospira Inc.
Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and confirmed in a sample bottle during retain sample inspection.
Lots: Lot #: 24-461-DJ*, Exp 12/14; 26-543-DJ*, Exp 02/15; 27-555-DJ*, 27-559-DJ*, Exp 03/15; *lot number may be followed by 01 - May 25, 2013 · Class II · Hospira Inc.
Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel
Lots: Lot 07-950-DJ Exp. Date 1JUL2013, 10-101-DJ Exp. Date 1OCT2013, and 10-102-DJ Exp. Date 1OCT2013 - Apr 8, 2013 · Class II · Hospira Inc.
Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection.
Lots: Lot #: 11-185-DJ*, 11-196-DJ*, Exp 1NOV2013; * may be followed by 01 or 02 - Feb 25, 2013 · Class II · Hospira Inc.
Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection.
Lots: a) Lot #: 06-804-DJ*, Exp 1JUN2013; and b) Lot #: 05-736-DJ*, Exp 1MAY2013; 09-066-DJ*, Exp 1SEP2013. *Note: the lot number may be followed by 01 or 02. - Nov 15, 2012 · Class II · Hospira Inc.
Presence of Particulate Matter: Visible particulate and particulate embedded in vials were observed during retain inspection.
Lots: Lot #: a) 95-070-DJ, Exp 11/01/12; 04-584-DJ, 04-652-DJ, Exp 04/01/13; 05-718-DJ, Exp 05/01/13; 06-815-DJ, Exp 06/01/13; b) 04-525-DJ, 04-530-DJ, 04-641-DJ-04-646-DJ, Exp 04/01/13; c) 02-291-DJ, Exp 02/01/13; 05-725-DJ, 05-732-DJ, Exp 05/01/13; 07-925-DJ, Exp 07/01/13; 09-065-DJ, Exp 09/01/13; 10-1… - Aug 29, 2012 · Class II · Hospira Inc.
Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain inspection.
Lots: Lot No: a) 93-857-DJ, 93-896-DJ, Exp 1SEP2012; 04-515-DJ, Exp 1APR2013; 06-802-DJ, Exp 1JUN2013; b) 01-175-DJ, Exp 1JAN2013; 04-565-DJ, Exp 1APR2013; c) 03-388-DJ, Exp 1MAR2013; The lot number may be followed by 01 or 02 - Aug 3, 2012 · Class II · Hospira Inc.
Presence of Particulate Matter: A single visible particulate was observed and confirmed in a sample bottle during retain inspection.
Lots: 07-893-DJ, exp. 7/2013, 10-123-DJ, 10-125-DJ, exp. 10/2013 - Apr 11, 2012 · Class II · Hospira, Inc.
Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel
Lots: Lot #: a) 03440DJ*, Exp 1MAR2013; b) 07947DJ, Exp 1JUL2013; 10134DJ, Exp 1OCT2013; Note: * the lot may be followed by 01.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Propofol: every company that makes it
- Form
- injection, emulsion, intravenous
- Strength
- 10 mg per 1 mL
- Approval
- ANDA ANDA077908
- On the market since
- May 22, 2022
- Package NDCs
0409-6010-020409-6010-25- Official label
- DailyMed (National Library of Medicine), updated Aug 13, 2026
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